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Using Non-Fluoroscopic Imaging Devices to Decrease Radiation Exposure During Ablation of Supraventricular Tachycardia

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ClinicalTrials.gov Identifier: NCT00979303
Recruitment Status : Completed
First Posted : September 18, 2009
Results First Posted : March 8, 2018
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
Christina Yumi Miyake, Boston Children's Hospital

Brief Summary:
The purpose of this study is to determine whether the additional use of non-fluoroscopic imaging modalities can decrease the use of radiation exposure during standard ablation procedures for supraventricular tachycardia (SVT) in children.

Condition or disease Intervention/treatment Phase
Supraventricular Tachycardia Device: Intracardiac echocardiography and 3D navigational system Not Applicable

Detailed Description:
The standard of care for children undergoing SVT ablation is radiation (fluoroscopy) to see the heart. Non fluoroscopic imaging tools have been utilized for adult atrial fibrillation procedures. These tools utilize magnetic fields to visualize the heart without using radiation. The purpose of this study was to determine if these 3D mapping tools could reduce radiation exposure during SVT ablation procedures could be performed using these 3D tools.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intent to treat use of non fluoroscopic mapping system with traditional fluoroscopic mapping system during elective catheter ablation in children 8-17 with normal cardiac anatomy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Adjunct Use of Non-Fluoroscopic Imaging Devices to Decrease Radiation Exposure During Ablation of Supraventricular Tachycardia
Actual Study Start Date : January 9, 2009
Actual Primary Completion Date : September 28, 2009
Actual Study Completion Date : May 28, 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Control Group
Control Patients - Undergo ablation procedures with radiation/fluoroscopy only
Experimental: Study Group
Study Group Patients - Undergo ablation procedures using intracardiac echocardiography and 3D navigational system in addition to radiation.
Device: Intracardiac echocardiography and 3D navigational system
Patients assigned to the intervention group will receive both intracardiac echocardiography as well as a 3D navigational system in addition to fluoroscopy during their ablation procedure.
Other Names:
  • AcuNav Intracardiac Echocardiography
  • NavX 3D navigational system
  • CARTO 3D navigational system



Primary Outcome Measures :
  1. Total Fluoroscopy Time [ Time Frame: During the Ablation procedure ]
    Total fluoroscopy time in minutes


Secondary Outcome Measures :
  1. Total Radiation Exposure [ Time Frame: During Ablation Procedure ]
    Total radiation exposure measured in mGy



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Ages Eligible for Study:   8 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >/=8
  • Weight >/=25kg
  • Structurally normal heart (no major cardiac defects)
  • History of SVT
  • No prior history of cardiac surgery or ablation

Exclusion Criteria:

  • Congenital Heart Disease
  • Prior history of cardiac surgery or ablation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00979303


Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Investigators
Principal Investigator: Christina Y. Miyake, MD Boston Children’s Hospital

Study Data/Documents: Archived consent, protocol and analytic plan.  This link exits the ClinicalTrials.gov site
Study completed prior to change in common rule. Requests should be directed to the investigation team at Boston Children's Hospital through mark.alexander@cardio.chboston.org

Publications of Results:
Responsible Party: Christina Yumi Miyake, Fellow, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT00979303     History of Changes
Other Study ID Numbers: 08110505
First Posted: September 18, 2009    Key Record Dates
Results First Posted: March 8, 2018
Last Update Posted: March 8, 2018
Last Verified: February 2018

Keywords provided by Christina Yumi Miyake, Boston Children's Hospital:
Pediatric
Electrophysiology
Ablation
Radiation
Devices
SVT

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Supraventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes